Trial Information

It will be a double-blind, placebo-controlled, randomized trial. Patients scheduled for
external-beam radiotherapy for prostate cancer will start using tadalafil 20 mg or placebo
the first day of radiation. The blinded medication (active drug or placebo) has to be taken
once every two days starting the day of the first radiation up to 12 months (52 weeks) after
radiotherapy. The active drug or placebo may be taken at bedtime unrelated to sexual
activity. In case of side effects the dose can be reduced to 10 mg. Erectile function will
be assessed every 3 months up to 6 weeks (week 58) after discontinuation of drug treatment
by using questions 3 and 4 of the International Index of Erectile Function (IIEF).
Responders (maintained erectile function) are defined as having a combined score of >=8 for
the IIEF questions 3 and 4.

Inclusion Criteria:

1. Men, at least 18 years of age, willing to participate in the study and willing to
regularly attempt sexual activity.

2. Patients with histologically proven prostate cancer.

3. Provide signed informed consent.

4. Patients with normal erectile function defined as a combined score >=8 of questions 3
and 4 of the IIEF.

5. Agree not to use any other ED treatment during the study.

Exclusion Criteria:

1. Use of any treatment for ED before the start of the study.

2. History of pelvic surgery (including radical prostatectomy)

3. History of penile implant

4. The presence of penile deformity that makes sexual intercourse difficult or
impossible.

5. Patients with chronic stable angina treated with long-acting nitrates, or patients
with chronic stable angina who have required short-acting nitrates in the last 90
days, or angina occurring during sexual intercourse in the last 6 months.

6. Patients with unstable angina, history of myocardial infarction or coronary artery
bypass graft surgery or percutaneous coronary intervention (eg, angioplasty or stent
placement) within 90 days before screening.

7. Any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart
rate >100 bpm) at rest despite medical or device therapy, or any history of
spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for 30
sec) despite medical or device therapy, or the presence of an automatic internal
cardioverter-defibrillator.

8. A history of sudden cardiac arrest despite medical or device therapy.

9. Any evidence of congestive heart failure or a new, significant conduction defect
within 90 days before screening.

10. Systolic blood pressure >170 or <90 mm Hg or diastolic blood pressure >100 or <50 mm
Hg, or patients with a history of malignant hypertension.

11. History of significant central nervous system injuries (including stroke and spinal
cord injury) within the 6 months before screening.

12. History of HIV infection.

13. Any condition that would interfere with the patient’s ability to provide informed
consent or comply with study instructions, would place patient at increased risk, or
might confound the interpretation of the study results.

14. Treatment with cancer chemotherapy.

15. History of drug, alcohol, or substance abuse within the 6 months before screening.

16. Have any condition, limitation, or disease that could, in the judgment of the
investigator, preclude evaluation of response to tadalafil.

Type of Study:

Interventional

Study Design:

Outcome Measure:

To assess the efficacy, and safety, of 20 mg tadalafil once every 2 days, in comparison with placebo, to maintain erectile function of patients undergoing external-beam radiotherapy for prostate cancer.

Principal Investigator

Luca Incrocci, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Erasmus MC

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

2004-165

NCT ID:

NCT00215631

Start Date:

October 2005

Completion Date:

November 2005

Related Keywords:

Prostate Cancer

Erectile Dysfunction

prostate cancer

radiotherapy

erectile dysfunction

tadalafil

Prostatic Neoplasms

Erectile Dysfunction

Name

Location

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